Hypertriglyceridemia Clinical Trial
— OMEGAOfficial title:
Omacor: Measures of Endothelial Function and triGlyceride Alteration
Verified date | February 2018 |
Source | Penn State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the cardiovascular and lipid effects of two doses of an omega-3 fatty acid concentrate in a group of people who normally are not treated for high lipids.
Status | Completed |
Enrollment | 28 |
Est. completion date | January 2009 |
Est. primary completion date | January 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility |
Inclusion Criteria: - triglycerides 150-500 mg/dL - age 21-65 years - generally healthy - body mass index (BMI) 20-39 kg/m2 Exclusion Criteria: - smoking - premenopausal (if female) - use of hormone replacement or oral contraceptives - use of lipid lowering or blood pressure medication - hypertension (blood pressure > 150/95 mm Hg) - peripheral vascular disease - heart disease, diabetes, or stroke - inflammatory disease (e.g. rheumatoid arthritis or Crohn's) - elevated liver enzymes - high intake of omega-3 containing foods - allergy to adhesive or latex - use of aspirin, anticoagulants, or SSRI |
Country | Name | City | State |
---|---|---|---|
United States | Penn State University General Clinical Research Center | University Park | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Penn State University | Reliant Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lipid Profile | Plasma/serum samples were analyzed at baseline and at the end of each 8-week treatment period to evaluate the effect of P-OM3 dose on triglycerides, HDL-C, LDL-C, and total cholesterol. | 8 weeks | |
Primary | Flow-mediated Dilation (FMD) | Effect of P-OM3 dose on FMD, which is measured as percent change in brachial artery diameter at peak dilation vs. baseline following a 5-minute occlusion period. | 8 weeks | |
Primary | Blood Pressure | Effect of P-OM3 dose on blood pressure | 8 weeks | |
Primary | Heart Rate | Effect of P-OM3 dose on heart rate | 8 weeks | |
Secondary | Erythrocyte Fatty Acids | Effect of P-OM3 dose on the percent concentration of select omega-3 fatty acids in red blood cells | 8 weeks | |
Secondary | Cytokine Inflammatory Markers | Effect of P-OM3 dose on concentrations of circulating inflammatory markers in plasma | 8 weeks | |
Secondary | Fasting Glucose | Effect of P-OM3 dose on fasting glucose | 8 weeks | |
Secondary | Psychosocial Profile Questionnaires | Effect of P-OM3 dose on psychosocial questionnaires: Perceived Stress Scale (PSS) 14 questions, scored 0-4 based on how often the subject felt certain emotions Scores: 0 to 40; higher scores indicate higher perceived stress Spielberger State Anxiety Inventory Levels of state anxiety (situational) and trait anxiety; 40 items scored by a Likert scale Scores: 20 to 80; higher scores indicate higher levels of anxiety Positive and Negative Affect Scales (PANAS) Two 10-item scales; each item is rated on a Likert scale of 1 (not at all) to 5 (very much). Scores: 10 to 50, with higher scores representing higher levels of positive or negative affect Center for Epidemiologic Studies Depression (CES-D) Scale 20 questions about symptoms of depression in the past week Scores: 0 to 60; higher scores indicate more symptomology. Score of 16 or higher indicates a risk for depression and should be followed by further evaluation by a qualified health professional |
8 weeks | |
Secondary | C-reactive Protein (CRP) | Effect of P-OM3 dose on the plasma concentration of the inflammatory marker CRP | 8 weeks | |
Secondary | Fasting Insulin | Effect of P-OM3 dose on fasting insulin | 8 weeks | |
Secondary | Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and Quantitative Insulin Sensitivity Check Index (QUICKI) | Effect of P-OM3 dose on the homeostatic model assessment of insulin resistance (HOMA-IR) and the quantitative insulin sensitivity check index (QUICKI). HOMA-IR calculates an index of insulin resistance and is calculated as follows: HOMA-IR = (glucose mg/dL * insulin mU/L) / 405. QUICKI is calculated as follows: QUICKI = 1 / (log(fasting insulin µU/mL) + log(fasting glucose mg/dL)). |
8 weeks |
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